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About OMICS Group
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Complications of Fillers
Alain Tenenbaum, M.D, PhD, D.Sc
Facial Plastic Surgeon,
Switzerland
4
Thanks to friendly Collaborators who shared with me their pictures
• Dr Junfeng Du,China, • Dr Jean Hebrant,Belgium • Dr Igor Rudenko,Ukraine • Prof Milanov, Plastic Surgery, Russia • Dr Sidorenkov,Plastic Surgery,Russia • Dr Luitgaard Wiest, Dermatology, Germany • Dr Romulo Mene, Plastic Surgery, Brasil • Dr Denis Valente, Plastic Surgery, Brasil • Dr Ziya Saylan,Cosmetic Surgery, Turkey • Dr Georghy, General Surgery,Australia • Prof Gottfried Lemperle, Plastic Surgery, USA • Prof Hirotaro Fukuoka, Plastic Surgery,Japan • Prof Ivo Pitanguy,Brazil • Prof Luiz Toledo, ISAPS Professor,Dubai, UAE • AND OTHERS
What is a common complication
14/08/2015
American Society of Plastic Surgeons statistics on the number of injections made per year by surgeon members
COMPLICATIONS
MINOR
– Dolor
– Edema
– Ecchymosis
– Hiperemias
– Asymetries
– Irregularities
– Motor Anaesthesia
– Herpes activation
– Collections Formations
MAJOR
• Nodules
• Necrosis
• Granulomas
• Late Edema
Locals
Chronic
Acute
Inflammation
Infection
Trombosis
necrosis
Nodules
Granulomas
Migration
Late Inflammation
Pseudo-seroma
Systemic Coadjuvant Pathologies
( Sarcoidose ?)
Complications
Collateral Effects on Animals SR
PMMA
01 animal died 8 weeks after
injection
Metacrill
01 animal died after 2 weeks
Abscess in the skins back of 01
animal
Multiple hepatic abscess
Dimethylsiloxane
02 animals died
01 hepatic abscess in 01 animal
01 Tumor in the foot of 01 animal
Hepatic abscess in some lobuls
Abscess in the skins back
Restylane
02 animais died same day of
injection
Eosinophilic Infiltration Hipersensibility?
Cheloid in the skins back
Multiple hepatic abscesses in all
lobuls
Thesis of Plastic Surgeon presented at SBCPR Annual Congress 9 years ago
Artecoll
10
Fillers are silent killers and medical thrillers
2 Massive killers Fillers are silent killers
And medical thrillers
Lipodystrophies be careful with publications !!!
Before After
20 Mhz 7.5 Mhz
14
EPIDERMIS
DERMIS
HYPODERMIS
20 Mhz
15
Ideal filler : Homogeneous Width of the dermis
16
Who is the responsible ? MD have to gain back their authorities over ignorant and dangerous
burocrats
• The product ? • The physician? • The patient? • The notified body ? Anvisa ,CE, FDA,KFDA,Invicma,Digemid
& others !!! • The Health Ministry ? • The medias ? • The bad copies made in some countries ? (Ecuador,South
Korea,Argentina,Venezuela,Brasil,China,India,..) • Ignorant antideontologic colleagues
Nodules & Granulomas
GRANULOMA
• Tissular reaction mediated by monocyts and usually caused by not absorbable agents
• Featured by hardening in all treated areas
• Differential Diagnosis is clinical
NODULE
• Tissular reaction mediated by fibroblasts which may occur by product accumulation or organizedhematoma.
• Featured by hardening in some treated areas
• Differential Diagnosis is clinical
TREATMENT OF COMMON COMPLICATIONS POST FILLERS
• nodules – surgical resection
• granulomas - corticoid intra-lesional infiltration
• Large necroses – reconstructive surgery
• Partial necroses - chemical or surgical debridement
Generalities
Nodules : Surgery
Good Pronostic
• Technical errors
Granulomas : Medicine
Bad Pronostic
• Technical errors
( anamnesis, US20 Mhz,indications)
• Chemical mistakes
• Patient lyers
• Unknown etiologies
Nodules Granulomas
Appear 1-3 months Slowly
6-36 months Suddenly after initial satisfaction
Localization Some isolated injected sites ( lips, crows feet … )
All injected sites at the same moment
Size Stable Growing
Border Confined by fibrous capsula Fingerlike project into tissue
Histology Foreign Body Reaction Packed material as implanted
Foreign Body Granuloma Scattered in cellular reaction
Evolution-Persistance As long as fillers remain ( resorbable, permanent) ??
Seem to disappear if untreated after 1 -5 years
Aspect Skin normal No edema
Skin discoloration With edema
Treatment surgical No corticoids
medical Corticoids + - 5 FU
Borders
Nodule Confined by fibrous capsula
Granuloma
Fingerlike project into tissue
Nodules & Granulomas Mechanisms
NODULE : 5 Mechanisms
1. Inadequate Quantity of injected material
2. Product placed too superficially
3. Lack of proper distribution of the filler
4. Organized hematoma with calcification
5. Application in inappropriate plan or layer
GRANULOMA : 3 Mechanisms
1. Foreign bodies in the injected material
2. Microspheres too small causing acute inflammatory reaction.
3. Pathological Biofilm
MD RESPONSIBLE SURGERY -> GOOD PRONOSTIC
WHO IS RESPONSIBLE? MEDICAL TREATMENT -> PRONOSTIC ???
23
Reported Possible causes of granulomas
after injected fillers
High Correlations
Mixing fillers in
same location
Auto immune
thyreosis
Facial trauma
Systemic
infections
acupuncture Facelift
operation
Sinusitis Hyperthyreosis Dental focus
Pharyngitis Colitis ulcerosa Paradontosis
Bronchitis Morbus crohn mesotherapy
Pleurisy Pemphigus botulinum
Enteritis Sarcoidosis HRT??
Pyelonephritis Breast cancer Encephabol
Flu like syndrom Psychological
shock
• 5FU 5% • Triancinolon 4% • Xilitol 2% • Lidocaín 2% • Adrenalin 1:50.000 • H20 for injection q.s.p. 10ml • 4 Cycles INTRALESIONAL 1 X week • Prednison 60mg, 40mg, 20mg P.O. • Alopurinol 300mg P.O. 2 X day – 45days • imiquimod 250mg topic 2 X day– 45days
Treatment tentatives of Granulomas
Mean time until appearance of adverse reaction after
injection of Fillers
Biodegradable Fillers
HA: 3.2 ± 6.0 months
PLA: 5.5 ± 6.3 months
Permanent Fillers
PAG: 7.O ± 10.6 months
HEMA: 12.3 ± 13.7 months
PMMA: 25.5 ± 37.1 months
FILLERS
Biodegradable
Resorbable
Collagen
HA
hyaluronic acid
HA
Autologous fat
lipofilling
PLA
Poly lactic acid
Synthetic
Non Resorbable
CaHA
Ca Hdroxyapatite
Silicons
and others Acrylats
PAG 聚烷撑二醇
hydrogel with
some monomers
METHYLACRYLA
T
pmma
HEMA,EMA
Mixed biphasic
Resorbable Collagen fillers(2)
Side effects : Granuloma,Nodule,Necrosis
Dr. L.Wiest
Resorbable Collagen fillers(3)
Side effects : Granuloma,Nodule,Necrosis
FILLERS
Biodegradable
Resorbable
Collagen
HA
hyaluronic acid
HA
Autologous fat
lipofilling
PLA
Poly lactic acid
Synthetic
Non Resorbable
CaHA
Ca Hdroxyapatite
Silicons
and others Acrylats
PAG
hydrogel with
some monomers
METHYLACRYLA
T
pmma
HEMA,EMA
Mixed biphasic
Granulomas with Hyaluronic acid
Resorbable Hyaluronic Acid fillers(2) Side effects : Granuloma,Nodule,Necrosis
Dr. L.Wiest
Hyaluronic acid
Persisting oedema after Hyaluronic acid
Persisting oedema after Hyaluronic acid
HA Complication for medical augmentation mammaplasty
FORBIDDEN IN FRANCE SINCE 05 SEPTEMBER 2011 BY AFSSAPS
HA Spontaneous 自发的Perforation穿孔 for medical augmentation mammaplasty
FORBIDDEN IN FRANCE SINCE 05.09.2011 BY
AFSSAPS
FILLERS
Biodegradable Resorbable
Collagen
HA hyaluronic acid
HA
Autologous fat
lipofilling
PLA Poly lactic acid
Synthetic Non Resorbable
CaHA Ca Hdroxyapatite
Silicons and others
Acrylats
PAG hydrogel with some
monomers
METHYLACRYLAT
pmma
HEMA,EMA
Mixed biphasic
Granuloma and Migration post autologous fat
lipofilling
Parodontosis? Dental Focus?
FILLERS
Biodegradable Resorbable
Collagen
HA hyaluronic acid
HA
Autologous fat lipofilling
PLA Poly lactic
acid
Synthetic Non Resorbable
CaHA Ca Hdroxyapatite
Silicons and others
Acrylats
PAG hydrogel with some
monomers
METHYLACRYLAT
pmma
HEMA,EMA
Mixed biphasic
Resorbable Polylactic Acid fillers(1) Side effects : Granuloma,Nodule,Necrosis
PLA
PLA Polylactic Acid PLA
PLA granuloma
PLA infected
PLA INFECTED
–Polylactic acid Granuloma on foreign body
without anfractuosities
47
,,PLA,,Inclusion or Granule inside the gigant cell
Fillers & endoprosthesis
FILLERS
Biodegradable Resorbable
Collagen
HA hyaluronic acid
HA
Autologous fat lipofilling
PLA Poly lactic acid
Synthetic Non Resorbable
CaHA Ca
Hydroxyapatite
Silicons and others
Acrylats
PAG hydrogel with some
monomers
METHYLACRYLAT
pmma
HEMA,EMA
Mixed biphasic
Synthetic not resorbable fillers(1)
Ca OH apatite
Side effects : Granuloma,Nodule,Necrosis
Fillers & endoprosthesis
FILLERS
Biodegradable Resorbable
Collagen
HA hyaluronic acid
HA
Autologous fat lipofilling
PLA Poly lactic acid
Synthetic Non Resorbable
CaHA Ca Hdroxyapatite
Silicons and others
Acrylats
PAG hydrogel with some
monomers
METHYLACRYLAT
pmma
HEMA,EMA
Mixed biphasic
Silicon Injected in 1979
Thai Transsexual using silicon for ,, feminilization,, Granulomas made her not masculine nor feminine nor
trans but looking like a Monster !
Granulomas for Face Feminilisation instead of 11 Operations Facial Plastic Surgery !
Silicons Granuloma in the deep dermis :
low destroyer- less inflammation
FILLERS
Biodegradable Resorbable
Collagen
HA hyaluronic acid
HA
Autologous fat lipofilling
PLA Poly lactic acid
Synthetic Non Resorbable
CaHA Ca Hdroxyapatite
Silicons and others Acrylats
PAG hydrogel with some
monomers
METHYLACRYLAT
pmma
HEMA,EMA
Mixed biphasic
57
COMPLICATIONS. OF ACRYLATS
HYDROGELS FILLERS
Migration
Geleoma formation
Inflammation
Purulo-necrotic process
Trophic disturbances of the tissues
Aesthetic problems
Impossibility of the complete gel removal.
7 Risk factors of Acrylats
Hydrogel
Geleomas
Monomers
Migration
Heavy Metallic Ions
Biofilm
Purulo Necrotic Process
Mixed Biphasics
THE WORST ONES
Hydrolysis
Inflammation
Sterilisation else than
gamma rays
Impossibility of Complete Gel Removal
Acrylats Classification by Alain TENENBAUM
Risks factors of Acrylats(1)
HYDROGEL
contact lenses
Are NOT A HYDROGEL
MADE IN CHINA = CHEAP TO BUY = HIGH COST FOR COMPLICATIONS
Amazing Gel
6
2 GELEOMA FORMATION.
Focus of calcification
Geleomas in the culf
63 63
5 years after the retromammary
PAAG injection.
Multiple geleomas of the mammary glands.
GELEOMA FORMATION.
64 64
GELEOMA FORMATION.
Geleomas of the mammary glands.
65
GELEOMA FORMATION.
Geleomas of the mammary glands.
66
Fibrous capsule
GELEOMA FORMATION.
Geleomas of the mammary
glands.
7 Risk factors of Acrylats
Hydrogel
Geleomas
Monomers
Migration
Heavy Metallic Ions
Biofilm
Purulo Necrotic Process
Mixed Biphasics
THE WORST ONES
Hydrolysis
Inflammation
Sterilisation else than
gamma rays
Impossibility of Complete Gel Removal
Acrylats Classification by Alain TENENBAUM
POLYACRILAMIDE HYDROGEL 水凝胶
FILLER (PААG)
Inert
Biocompatible
Resistible for biological
degradation with time.
Hydrophilic ,,polymer ,,for
injection.
95-97% - water,
3-5% - true polymer.
But how many % true
monomers ?
Easy to inject , minimal tissue
trauma during procedure.
PERMANENT
- CH2 - CH - (CH2 - CH)n-1 - CH2 - CH -
C=O C=O C=O
NH NH NH
CH2
NH NH NH
C=O C=O C=O
- CH2 - CH - (CH2 - CH)n-1 – CH2 - CH -
69
Risks factors of Acrylats (2)
Monomer
DANGER
Peak at 220 nm = presence of monomers
( A.Tenenbaum)
Risks factors of Acrylats(2)
Dermis
POLYACRYLAMIDE
POLYACRYLAMIDE is colonised by Refringerent structures Fibroblasts ?
Naso genian sulcus Heterogeneous aspect
3 1/2 months after Injection
72
MIGRATION.
PAAG was injected 3 years ago for the calf thigh
correction.
7
3
PAAG was
injected into
the buttocks area.
MIGRATION.
3 years after the augmentation mammaplasty using PAAG.
MIGRATION.
Ultrasound examination
of calf.
Thin fibrous capsule
Accumulation of the gel under the fascia. Fascia
Gel accumulation in the subcutaneous fat.
MIGRATION.
15 days after the
retromammary gel injection.
Migration of the gel to the subcutaneous fat.
MIGRATION. Ultrasound examination
of the mammary glands.
77
Gel
MRI of the mammary
glands.
MIGRATION.
7 Risk factors of Acrylats
Hydrogel
Geleomas
Monomers
Migration
Heavy Metallic Ions
Biofilm
Purulo Necrotic Process
Mixed Biphasics
THE WORST ONES
Hydrolysis
Inflammation
Sterilisation else than
gamma rays
Impossibility of Complete Gel Removal
Acrylats Classification by Alain TENENBAUM
79
Risk factors of Acrylats(3)
Argiform has metallic ions
Argiform
Dr. R. Mené
7 Risk factors of Acrylats
Hydrogel
Geleomas
Monomers
Migration
Heavy Metallic Ions
Biofilm
Purulo Necrotic Process
Mixed Biphasics
THE WORST ONES
Hydrolysis
Inflammation
Sterilisation else than
gamma rays
Impossibility of Complete Gel Removal
Acrylats Classification by Alain TENENBAUM
81
BIOFILM
•Structured colonies of micro encapsulated in a matrix which
surround a foreign body
•Contains nutrients and metabolites which protect the micro
organisms for a long period.
•Almost all bacteries can lead to a biofilm
•Biofilms are reponsible of granulomas, aseptic inflammatory
reactions and late infections.
Complications of Biofilm
83
PURULO-NECROTIC PROCESS.
Chronic inflammation.
84
PURULO-NECROTIC PROCESS.
85 85
Outcomes of the recurrent
purulent mastitis.
After four surgical procedures
Initial view
PURULO-NECROTIC PROCESS.
86
Cavernous body necrosis after the
PAAG injection six years ago for the
impotence treatment.
PURULO-NECROTIC PROCESS.
87
Polyalkylamide with abscess
Polyalkylamide Complication
7 Risk factors of Acrylats
Hydrogel
Geleomas
Monomers
Migration
Heavy Metallic Ions
Biofilm
Purulo Necrotic Process
Mixed Biphasics
THE WORST ONES
Hydrolysis
Inflammation
Sterilisation else than
gamma rays
Impossibility of Complete Gel Removal
Acrylats Classification by Alain TENENBAUM
90
INFLAMMATION.
Acute inflammation of calf soft
tissue in the area of the gel
injection.
Site of
lymphocytes
inflammation.
Macrophages.
At palpation :
like wet sugar
(A.Tenenbaum)
7 Risk factors of Acrylats
Hydrogel
Geleomas
Monomers
Migration
Heavy Metallic Ions
Biofilm
Purulo Necrotic Process
Mixed Biphasics
THE WORST ONES
Hydrolysis
Inflammation
Sterilisation else than
gamma rays
Impossibility of Complete Gel Removal
Acrylats Classification by Alain TENENBAUM
Mixed biphasic ones
so called resorbable fillers with longer duration
FILLERS
Biodegradable Resorbable
Collagen
HA hyaluronic acid
HA
Autologous fat lipofilling
PLA Poly lactic acid
Synthetic Non Resorbable
CaHA Ca Hdroxyapatite
Silicons and others
Acrylats
PAG hydrogel with
some monomers
METHYLACRYLAT
pmma
HEMA,EMA
Risk factors of Acrylats(4)
Metacrylates
CH2OH CH3
PHEMA-EMA Acrylic hydrogel
Copolymer of
Hydroxyethylmetacrylate
(HEMA) & Ethylmetacrylate
(EMA)
PMMA
94
PMMA Infection
95
Risk factors of Acrylats(4)
METACRILATE
Risk factors of Acrylats(4)
98
2 days after PMMA
99
After PMMA
Granuloma treated with 5 FU on depressed scar
treated with Dermalive--- HA+PMMA
101
The treated granuloma by 5 FU + Corticoids still attacks hardly the dermis
( Dermalive and depressed scar)
102
Gigant cell after Dermalive (Metacrylate + Hyaluronic acid)
103
Surgical treatment of the Dermalive Granuloma pre treated
by 5 FU and corticoids
104
Histology post Surgery Foreign body granulomas with giant epithelioid cells
Infection 11years after Artecoll
Infected Acryloma 2 years post Artecoll
Artecoll Infected Permanent Redness and Hardening
108
Artecolls Granuloma big destroyer 1 : Granuloma 2 : Dermis
7 Risk factors of Acrylats
Hydrogel
Geleomas
Monomers
Migration
Heavy Metallic Ions
Biofilm
Purulo Necrotic Process
Mixed Biphasics
THE WORST ONES
Hydrolysis
Inflammation
Sterilisation else than
gamma rays
Impossibility of Complete Gel Removal
Acrylats Classification by Alain TENENBAUM
http://cosmetic-dermatology-forum.com/ [email protected]
CORRECTION OF THE CONSEQUENCES OF THE
PAAG INJECTION.
Gel removal
One-stage gel removal and
prosthesis placement
Secondary gel removal and correction
111
GEL REMOVAL.
112
Before operation
Two month after replacement, 120 cc.
ONE-STAGE GEL REMOVAL AND PROSTHESIS
REPLACEMENT.
113
Two years after gel removal.
IMPOSSIBILITY OF THE COMPLETE GEL
REMOVAL.
MRI of the culf.
Aesthetic Medicine Mini Invasive Procedures leading to
More Invasive Surgery
• Cases of Mammary breast fillers (Macrolane,Aquamid, Amazinggel ……..)
• Incomplete removal is the problem
115
ONE-STAGE GEL REMOVAL AND PROSTHESIS REPLACEMENT.
116 116
One year after the gel removal and retromammary endoprosthesis
replacement, 225cc.
ONE-STAGE GEL REMOVAL AND PROSTHESIS REPLACEMENT.
Before operation
117 117
Two years after augmentation mammaplasty using PAAG.
ONE-STAGE GEL REMOVAL AND PROSTHESIS REPLACEMENT.
Six month after the gel removal and retropectoral endoprosthesis
replacement, 225cc.
118 118
Silicone prosthesis
Vestige of the PAAG in mammary gland tissue
over prosthesis.
Right mammary gland in seven days after
PAAG removal.
IMPOSSIBILITY OF THE COMPLETE GEL REMOVAL.
119 119
IMPOSSIBILITY OF THE COMPLETE GEL REMOVAL.
One year after the gel removal and retromammary prosthesis
replacement, 450.
120
Silicone prosthesis
Accumulation
of the gel in the
mammary gland tissue
IMPOSSIBILITY OF THE COMPLETE GEL REMOVAL.
MRI of the mammary
glands.
Gel in the prosthesis
capsule cavity.
IMPOSSIBILITY OF THE COMPLETE GEL REMOVAL.
122
Complication of Buttock Gel Injection
Patient with skin necrosis one month after
removal of gel injected in the buttocks. luiztoledo.com – Dubai – ISAPS Professor
Complication of Buttock Gel Injection
Patient with skin necrosis one month after
removal of gel injected in the buttocks. luiztoledo.com – Dubai – ISAPS Professor
Conclusions
• Authorities should not have competences to authorize to put on the market fillers or other medical devices.
• Don t be influenced by key speakers sponsored by big companies in big commercial congresses
• Knowledge and Experience Forum between independent MD is a must
• Patients should be too responsabilised as they mostly lie and change of physician
• Do not fall in commercial advertisements which seem to be scientific
• Not permanent fillers participate also to a high rate of complications , which are shadowed in commercial Congresses sponsored by big companies infiltrating their ,, key,, speakers .
www.facial-plasticsurgery.org
THANKS FOR YOUR KIND ATTENTION
Alain Tenenbaum
Facial Plastic Surgeon
M.D.,Ph.D.,D.Sc
Switzerland
Let us meet again..
We welcome you all to our future conferences of OMICS International
5th International Conference and Expo on
Cosmetology, Trichology & Aesthetic Practices
On
April 25-27, 2016 at Dubai, UAE
http://cosmetology-trichology.conferenceseries.com/